Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No Subjects enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to understand the diagnostic applications for this imaging technology and identify particular disorders to target for future clinical investigations. Images obtained with the Ossiview device will be correlated to other standard of care (SoC) testing including microscopic otoscopy, CT scans, MRIs, audiologic testing results, and surgical and pathology reports.
Optical Coherence Tomography (OCT) is an optical imaging technique that uses a low-coherence interferometer to produce depth-resolved scans in tissue. This study will explore the utility of this technology in otology patients presenting with various pathologies as well as normal subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ossiview | Device | Imaging of the ear using Optical Coherence Tomography |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic correlation with microscopic otoscopy | Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy | 6 months |
| Diagnostic correlation with CT scans | Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans | 6 months |
| Diagnostic correlation with Magnetic Resonance Imaging (MRI)s | Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs | 6 months |
| Diagnostic correlation with audiologic testing results | Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results | 6 months |
| Diagnostic correlation with surgical reports | Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports | 6 months |
| Diagnostic correlation with pathology reports | Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports | 6 months |
Not provided
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Target pathologies in the subject population are subjects with:
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deanne King, MD, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock, AR | Arkansas | 72205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided